PersonalFit Flex Connector

GUDID 07612367071727

Medela AG

Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable Breast pump support kit, reusable
Primary Device ID07612367071727
NIH Device Record Key671e0e0d-869a-4b90-a134-b1096d279521
Commercial Distribution StatusIn Commercial Distribution
Brand NamePersonalFit Flex Connector
Version Model Number101038233
Company DUNS488293218
Company NameMedela AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com
Phone1-800-435-8316
Emailcustomer.service@medela.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107612367071406 [Primary]
GS107612367071413 [Package]
Contains: 07612367071406
Package: [6 Units]
In Commercial Distribution
GS107612367071727 [Package]
Contains: 07612367071413
Package: [216 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGXPump, Breast, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-30
Device Publish Date2019-10-22

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07612367003575 - Change over valve2024-06-10 Change over valve
07612367003698 - Overflow protection device2024-06-10 Overflow protection device
07612367003735 - Reusable serial connector2024-06-10 Reusable serial connector

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